Recruiting

UPLIZNA

Sponsor:

Amgen

Code:

NCT05909761

Conditions

Neuromyelitis Optica Spectrum Disorder

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 15+

Healthy Volunteers: Not accepted

Interventions

UPLIZNA

Study Details

Brief summary:

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Conditions

Neuromyelitis Optica Spectrum Disorder

Pregnancy Related

Study ID

NCT05909761

Start date

Oct 15, 2026

Status verified date

Aug, 2026

Completion date

Oct 31, 2032

Anticipated

Primary completion date

Oct 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide informed consent
  • Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
  • Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception

Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

UPLIZNA

Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.

Primary outcome measure

  • Number of newborns with Major Congenital Malformations (MCMs) [ Time Frame: Minimum of 10 years ]
  • Number of newborns with Preterm birth [ Time Frame: Minimum of 10 years ]
  • Number of newborns with low birth weight [ Time Frame: Minimum of 10 years ]
  • Number of stillbirths [ Time Frame: Minimum of 10 years ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Amanda Piquet, MD

303-724-4644AMANDA.PIQUET@CUANSCHUTZ.EDU

Principal Investigator:

Dr. Amanda Piquet, MD

More Information

Sponsor

Amgen

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Neuromyelitis Optica Spectrum Disorder
  • Pregnancy
  • UPLIZNA
  • inebilizumab
  • birth complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-31.